510(k) K964960 ยท JGP Lowry (Colorimetric), Total Protein
VITROS CHEMISTRY PRODUCTS UPRO SLIDES
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Feb 18, 1997 |
| Received | Dec 11, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964960
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 8, 2016 | Ortho-Clinical Diagnostics VITROS Chemistry Products UPRO Slides, UPN 10758750000593,
Product Usage:
Quantitative measurement of total protein concentration in urine. Terminated |
JGP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.